Great Basin Scientific Completes Clinical Trial for Stool Bacterial Pathogens Panel
November 08 2016 - 7:00AM
Great Basin Scientific, Inc. (OTCQB:GBSN), a molecular diagnostics
company, announced today the successful completion of the clinical
trial of its second multiplex panel – the Stool Bacterial Pathogens
Panel. This is the first of two trials the Company has completed in
2016 and demonstrates the Company’s commitment to expand its
product menu of sample-to-result assays to diagnose infectious
disease. The Company will seek 510(k) clearance from the Food and
Drug Administration (FDA) as well as CE marking, and if cleared,
the Company believes that the Stool Bacterial Pathogens Panel will
provide significant assistance to hospitals and laboratories in
detecting common bacterial agents, including food borne pathogens,
that are suspected of causing acute gastroenteritis in patients.
Great Basin Scientific provides both low-plex and multiplex
testing on a single system. The Company’s Stool Bacterial Pathogens
Panel will simultaneously detect Salmonella species, Shigella
species, Shiga Toxin-producing E. coli species (stx1 and stx 2,
O157), and Camphylobacter species (C. jejuni and C. coli).
“We are excited about the on-time and successful completion of
the clinical trial for our Stool Bacterial Pathogens Panel, which,
if FDA clearance is obtained, will be the second multiplex panel
we’ll be able to offer the market. This trial completion is
representative of our continued strategy and commitment to
developing and delivering molecular diagnostics solutions to help
hospitals of all sizes combat the misdiagnosis and spread of
infectious disease and improve their antimicrobial stewardship,”
said Ryan Ashton, co-founder and Chief Executive Officer of Great
Basin Scientific.
Great Basin Scientific’s Stool Bacterial Pathogens Panel allows
for simultaneous detection of key bacterial pathogens and the
Company believes better supports customer needs, compared to
conventional tests that are labor intensive, requiring multiple
individual tests with poor sensitivity and long turnaround times
(96 hours). The Company’s multiplex assay allows for simultaneous
detection of important bacterial pathogens, offers an easy-to-use
workflow and a turnaround time of under two hours. The assay can
quickly detect pathogens from a patient’s preserved stool sample
with less than two minutes of few hands-on steps.
Great Basin Scientific initiated clinical trials for the Stool
Bacterial Pathogens Panel in April 2016. Great Basin Scientific
currently has four commercially available tests, the Staph ID/R
Blood Culture Panel, Shiga Toxin Direct Test, tests for Group B
Streptococcus (GBS), and toxigenic Clostridium difficile (C. diff).
The Company also has four tests in development phase; Nasal S.
aureus Pre-surgical Screen, Candida Blood Infections Panel, CT/NG
Test, and the Bordetella Direct test.
About Great Basin ScientificGreat Basin
Scientific is a molecular diagnostics company that commercializes
breakthrough chip-based technologies. The Company is
dedicated to the development of simple, yet powerful,
sample-to-result technology and products that provide fast,
multiple-pathogen diagnoses of infectious diseases. The Company’s
vision is to make molecular diagnostic testing so simple and
cost-effective that every patient will be tested for every serious
infection, reducing misdiagnoses and significantly limiting the
spread of infectious disease. More information can be found on the
company’s website at www.gbscience.com.
Forward-Looking Statements This press release
includes forward-looking statements regarding the Company’s
continuing business efforts related to its products, including but
not limited to statements regarding the Company’s intent to seek
510(k) clearance from the FDA for the Stool Bacterial Pathogens
Panel and CE marking, the potential future marketing of the the
Stool Bacterial Pathogens Panel if FDA clearance is obtained, the
potential benefits of the the Stool Bacterial Pathogens Panel for
the Company’s potential customers, planned tests to be brought to
clinical trial in 2016, expansion of the Company’s menu, the
Company’s development goals and other similar statements.
Forward-looking statements involve risk and uncertainties, which
could cause actual results to differ materially, and reported
results should not be considered as an indication of future
performance. These risk and uncertainties include, but are not
limited to: (i) our limited operating history and history of
losses; (ii) our ability to develop and commercialize new products
and the timing of commercialization; (iii) our ability to obtain
capital when needed; and (iv) other risks set forth in the
Company’s filings with the Securities and Exchange Commission,
including the risks set forth in the company’s Annual Report on
Form 10-K for the fiscal year ended December 31, 2015 and Quarterly
Report on From 10-Q for the quarter ended June 30, 2016. These
forward-looking statements speak only as of the date hereof and
Great Basin Scientific specifically disclaims any obligation to
update these forward-looking statements, except as required by
law.
Media Contact:
Nirav Suchak
ICR
646.277.1257
nirav.suchak@icrinc.com
Investor Relations Contact:
Betsy Hartman
Great Basin Scientific
385.215.3372
ir@gbscience.com